Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

May 15, 2014 – Eszopiclone (Lunesta): The U.S. Food and Drug Administration (FDA) has notified health professionals and their medical care organizations of a new warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Women and men are equally susceptible to impairment from Lunesta, so the recommended starting dose of 1 mg is the same for both. FDA approved changes to the Lunesta prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.

Methodology

Methods Used to Collect/Select the Evidence

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

2006 Guideline

Not stated

2011 Review Process

MEDLINE and PubMed were searched for updated literature related to the subject published between June 2009 and January 2011. This search is done annually and completed by the clinical practice committee vice-chair. If new literature does not change the content or scope of the original guideline, it is deemed to be current.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Expert Consensus

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Expert Consensus

Description of Methods Used to Formulate the Recommendations

This guideline was developed by an interdisciplinary workgroup, using a process that combined evidence and consensus-based approaches. Workgroups include practitioners and others involved in patient care in long-term care facilities. Beginning with a general guideline developed by an agency, association, or organization such as the Agency for Healthcare Research and Quality (AHRQ), pertinent articles and information, and a draft outline, each group works to make a concise, usable guideline that is tailored to the long-term care setting. Because scientific research in the long-term care population is limited, many recommendations are based on the expert opinion of practitioners in the field.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

External Peer ReviewInternal Peer Review

Description of Method of Guideline Validation

Guideline revisions are completed under the direction of the Clinical Practice Guideline Steering Committee. The committee incorporates information published in peer-reviewed journals after the original guidelines appeared, as well as comments and recommendations not only from experts in the field addressed by the guideline but also from "hands-on" long-term care practitioners and staff.

All American Medical Directors Association (AMDA) clinical practice guidelines undergo external review. The draft guideline is sent to approximately 175+ reviewers. These reviewers include AMDA physician members and independent physicians, specialists, and organizations that are knowledgeable of the guideline topic and the long-term care setting.

Recommendations

Major Recommendations

The algorithm Sleep Disorders in the Long-Term Care Setting is to be used in conjunction with the clinical practice guideline. The numbers next to the different components of the algorithm correspond with the steps in the text. Refer to the "Guideline Availability" field for information on obtaining the full text guideline.

The most frequent adverse effect of eszopiclone is an unpleasant taste.

Continuous use of benzodiazepine hypnotic agents should be discouraged in the long-term care setting because of the risk of side effects, physiological tolerance, and adverse effects on discontinuation. Adverse events such as memory impairment, falls, excessive daytime sleepiness, and accidents occur more often at higher doses and with the use of long-acting agents. In addition, prolonged use of long-acting benzodiazepines can lead to cognitive impairment, incoordination, and worsening of depression. These agents are associated with anterograde amnesia, rebound insomnia, and residual daytime sedation, especially at high doses. These adverse effects generally appear to be worse in the elderly.

Side effects of tricyclic antidepressants include anticholinergic effects and various degrees of suppression of rapid eye movement (REM) sleep.

Potential side effects of trazodone include induction of cardiac arrhythmias (in patients with heart disease) and orthostatic hypotension.

All antidepressants have potentially significant adverse effects, raising concerns about the risk-benefit ratio.

Patients with renal and hepatic insufficiency may be at greater risk for side effects from sedatives.

In patients with underlying obstructive sleep apnea, hypnotics can produce further nocturnal hypoxemia.

The anticholinergic and sedative side effects of tricyclic antidepressants and antihistamines can increase cognitive deficits.

Contraindications

Qualifying Statements

Qualifying Statements

This clinical practice guideline is provided for discussion and educational purposes only and should not be used or in any way relied upon without consultation with and supervision of a qualified physician based on the case history and medical condition of a particular patient. The American Medical Directors Association and the American Health Care Association, their heirs, executors, administrators, successors, and assigns hereby disclaim any and all liability for damages of whatever kind resulting from the use, negligent or otherwise, of this clinical practice guideline.

The utilization of the American Medical Director Association's Clinical Practice Guideline does not preclude compliance with State and Federal regulation as well as facility policies and procedures. They are not substitutes for the experience and judgment of clinicians and care-givers. The Clinical Practice Guidelines are not to be considered as standards of care but are developed to enhance the clinician's ability to practice.

Implementation of the Guideline

Description of Implementation Strategy

The implementation of this clinical practice guideline (CPG) is outlined in four phases. Each phase presents a series of steps, which should be carried out in the process of implementing the practices presented in this guideline. Each phase is summarized below.

Recognition

Define the area of improvement and determine if there is a CPG available for the defined area. Then evaluate the pertinence and feasibility of implementing the CPG

Assessment

Define the functions necessary for implementation and then educate and train staff. Assess and document performance and outcome indicators and then develop a system to measure outcomes

Implementation

Identify and document how each step of the CPG will be carried out and develop an implementation timetable

Identify individual responsible for each step of the CPG

Identify support systems that impact the direct care

Educate and train appropriate individuals in specific CPG implementation and then implement the CPG

Monitoring

Evaluate performance based on relevant indicators and identify areas for improvement

Evaluate the predefined performance measures and obtain and provide feedback

Additionally, process and quality indicators, a sample sleep log, and sleep rating scales can be found in the tables and appendices in the original guideline document.

Patient Resources

None available

NGC Status

This summary was completed by ECRI on June 23, 2006. This summary was updated by ECRI Institute on April 30, 2007, following the FDA advisory on Sedative-hypnotic drug products. This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on May 1, 2009 following the U.S. Food and Drug Administration advisory on antiepileptic drugs. The currency of the guideline was reaffirmed by the developer in 2011 and this summary was updated by ECRI Institute on May 11, 2012. This summary was updated by ECRI Institute on May 22, 2014 following the U.S. Food and Drug Administration advisory on Eszopiclone (Lunesta).

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the American Medical Directors Association (AMDA) and the American Health Care Association. Written permission from AMDA must be obtained to duplicate or disseminate information from the original guideline. For more information, contact AMDA at (410) 740-9743.

Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.